Variable Stiffness Guidewire Systems

ABSTRACT

A variable-stiffness guidewire system comprises an elongated flexible guidewire having a body and a guidewire head that is coupled to the body. The guidewire head is slidably moveable with respect to a guidewire collar of the body to adjust a stiffness of at least a portion of the guidewire. An insert is coupled to the guidewire and positioned between the guidewire head and the guidewire collar. The insert has a cross-sectional dimension no larger than a diameter of the body. The insert is configured to maintain a distance of the guidewire head from the guidewire collar to maintain a desired stiffness in the at least a portion of the guidewire.

STATEMENT OF RELATED APPLICATIONS

The present application claims the benefit of priority based on U.S.Provisional Patent Application Ser. No. 61/005,745, filed on Dec. 7,2007, and Provisional Patent Application Ser. No. 61/003,404, filed onNov. 15, 2007, both in the name of inventors Jay Wright and Samuel Ahn,and entitled “Variable Stiffness Guidewire Systems.”

TECHNICAL FIELD

The present disclosure relates generally to variable stiffness guidewiresystems.

BACKGROUND

FIG. 1A illustrates an example of an existing variable stiffnessguidewire system. As shown in FIG. 1A, the guidewire 10 is shown insidethe aorta A of a patient, wherein the guidewire 10 is shown insertedthrough a proximal opening of a catheter hub 12 of a catheter 14 andextending out of a distal opening or lumen 16 of the catheter 14. Theguidewire 10 shown in FIG. 1A has the ability to obtain variablestiffness to allow it to travel through different arterial branches andalso be stable such that the weight of the catheter 14 and/or otherinstruments (e.g. balloon catheter, sensors) or drugs may be deliveredto the desired location of the patient during a medical procedure. Thestiffness of the guidewire 10 is variably adjusted at the proximal endby the physician by pulling a head (not shown) of the guidewire away adesired distance from the coil body 18 of the guidewire. However, thehead of the guidewire 10 is small in diameter such that pulling the headaway from the coil body 18 usually requires the assistance of a tool 20.

As shown in FIG. 1A, the tool 20 is significantly larger than theguidewire 10 which allows the user to comfortably manipulate the tool 20and guidewire 10. However, this configuration of guidewire 10 and tool20 is disadvantageous considering that the tool 20 is relatively largerin diameter than that of the guidewire 10. Thus, the relatively largertool 20 does not allow loading and/or unloading of other components overthe catheter 14 at its proximal end 12 without first removing the tool20 from the guidewire 10. Removing the tool 20 may cause the loss oftension between the head and coil body of guidewire 10, therebyeffectively causing loss in the desired stiffness and stability in theguidewire to deliver the instruments or drugs to the desired locationwithin the patient.

Accordingly, a need exists for a variable stiffness guidewire system andtool which allows adjusting of the guidewire stiffness as well asmaintaining that stiffness to allow loading and unloading of instrumentsor drugs to the desired location within the patient without losing orcompromising the maintained stiffness in the guidewire.

OVERVIEW

Systems for the flexible catheterization of arterial branches by thepercutaneous entry techniques and, more particularly, such systemsprovide a variable stiffness guidewire for advancement into the lumensof branched arteries, vessels and cavities remote from the point ofentry of the catheter. The systems include removable devices forselectively maintaining guidewire stiffness by maintaining tension afterremoval of the actuator, or tool. Further, the system includes amechanism for selectively inserting the removable devices on thetensioned end of the guidewire.

In an embodiment, a variable-stiffness guidewire system comprises anelongated flexible guidewire having a body and a guidewire head that iscoupled to the body. The guidewire head is slidably moveable withrespect to a guidewire collar of the body to adjust a stiffness of atleast a portion of the guidewire. An insert is coupled to the guidewireand positioned between the guidewire head and the guidewire collar. Theinsert has a cross-sectional dimension no larger than a diameter of thebody. The insert is configured to maintain a distance of the guidewirehead from the guidewire collar to maintain a desired stiffness in the atleast a portion of the guidewire.

In an embodiment, a variable-stiffness guidewire system to be used withan external medical device. The system comprises an elongated flexibleguidewire which has a body and a guidewire head coupled to the body. Theguidewire head is slidably moveable with respect to a guidewire collarof the body to adjust a stiffness of at least a portion of theguidewire. The body is configured to move through a lumen of an externalmedical device. An insert is coupled to the guidewire and is positionedbetween the guidewire head and the guidewire collar to maintain adesired stiffness in the at least a portion of the guidewire. The inserthas a cross-sectional dimension such that a lumen of an external medicaldevice may be passed over the guidewire while the insert is coupledtherewith.

In an embodiment, a tension maintaining insert for use with avariable-stiffness guidewire that has a guidewire head that is moveablewith respect to a guidewire collar of a guidewire body to therebycontrol a stiffness of the guidewire. The insert comprises a cylindricalbody which has a cross-sectional dimension no larger than a diameter ofa body of a guidewire, the cylindrical body configured to be positionedbetween the guidewire head and the guidewire collar to maintain astiffness of the guidewire.

In any or all of the embodiments, the insert further comprises acylindrical body having a first end and a second end opposite from thefirst end, wherein the first end abuts the guidewire head and the secondend abuts the guidewire collar. The cylindrical body further comprisesan aperture running through the body between the first and second ends,wherein at least a portion of the aperture is configured to receive atensioning wire of the guidewire therein. The cylindrical body furthercomprises a plurality of opposing faces adjacent to the aperture, eachface extending between the first and second ends of the body, wherein aforce applied on to either or both of the opposing faces increases adiameter of the aperture. It is preferred that the cylindrical body iscircular in cross-section. In an embodiment, the cylindrical bodyfurther comprises a first portion and a second portion that are hingedlycoupled to one another and pivotably moveable with respect to oneanother between an open position and a closed position. In anembodiment, the cylindrical body further comprises a ridge featureextending from an end of the cylindrical body. It is contemplated thatthe cylindrical body further comprises a groove feature in an end of thecylindrical body.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and constitute apart of this specification, illustrate one or more examples ofembodiments and, together with the description of example embodiments,serve to explain the principles and implementations of the embodiments.

In the drawings:

FIG. 1 illustrates a variable stiffness guidewire in accordance with theprior art.

FIG. 2A illustrates a variable stiffness guidewire in accordance with anembodiment.

FIG. 2B illustrates a perspective view of the proximal end of theguidewire body in accordance with an embodiment.

FIG. 2C illustrates a side view of the distal end of the guidewire bodyin accordance with an embodiment.

FIG. 2D illustrates an end view of the distal end of the guidewire bodyin accordance with an embodiment.

FIGS. 3A-3B illustrate diagrams of guidewire tensioning toolembodiments.

FIGS. 4A-4D illustrate detailed views of the guidewire engagementmechanism in accordance with embodiments.

FIGS. 5A-5C illustrates perspective views of the guidewire engagingfeature of the tool in accordance with embodiments.

FIG. 6A illustrates a perspective view of the guidewire engaging featureof the tool 200 in accordance with an embodiment.

FIG. 6B illustrates a cross sectional view of the aperture of FIG. 6Aalong section B-B in accordance with an embodiment.

FIG. 6C illustrates an alternate cross sectional view of the aperture ofFIG. 6A along section C-C in accordance with an embodiment.

FIGS. 7-10 illustrate diagrams of tools in accordance with differentembodiments.

FIG. 11 illustrates a perspective view of a C-shaped guidewire insert inaccordance with an embodiment.

FIG. 12 illustrates a perspective view of a clamshell guidewire insertin accordance with an embodiment.

FIGS. 13A-13C illustrate perspective views of a selectively openableguidewire insert in accordance with an embodiment.

FIG. 13D illustrates a perspective view of a guidewire with combinablecartridges in accordance with an embodiment.

FIG. 14 illustrates a perspective view of an insert placement tool inaccordance with an embodiment.

FIG. 15 illustrates a perspective view of self-maintaining guidewire inaccordance with an embodiment.

FIG. 16 illustrates a perspective view of self-maintaining guidewire inaccordance with an embodiment.

FIG. 17A illustrates a side view of a combined tensioning and insertapplicator deployment tool in accordance with an embodiment.

FIG. 17B illustrates an elongated barrel tray in accordance with anembodiment.

FIG. 18 illustrates a top view of the combined tensioning and insertapplicator deployment tool in accordance with an embodiment.

FIG. 19 illustrates a broken view of a magazine for use in a deploymenttool in accordance with an embodiment.

FIGS. 20 and 21 illustrate operation of the magazine with the deploymenttool in accordance with an embodiment.

FIG. 22A illustrates a side view of a combined tensioning as well as ancartridge applicator and removal tool in accordance with an embodiment.

FIG. 22B illustrates operation of the magazine with the removal tool inaccordance with an embodiment.

FIG. 23A illustrates a perspective view of a guidewire with integratedtension head and tension maintaining mechanism in accordance with anembodiment.

FIG. 23B illustrates a perspective view of a guidewire with integratedtension head and tension maintaining mechanism in accordance with anembodiment.

FIG. 24 illustrates a side view of the integrated guidewire tensionmaintaining head with a deployment tool in accordance with such anembodiment.

DETAILED DESCRIPTION

Example embodiments are described herein in the context of a variablestiffness guidewire system. Those of ordinary skill in the art willrealize that the following description is illustrative only and is notintended to be in any way limiting. Other embodiments will readilysuggest themselves to such skilled persons having the benefit of thisdisclosure. Reference will now be made in detail to implementations ofthe example embodiments as illustrated in the accompanying drawings. Thesame reference indicators will be used throughout the drawings and thefollowing description to refer to the same or like items.

In the interest of clarity, not all of the routine features of theimplementations described herein are shown and described. It will, ofcourse, be appreciated that in the development of any such actualimplementation, numerous implementation-specific decisions must be madein order to achieve the developer's specific goals, such as compliancewith application- and business-related constraints, and that thesespecific goals will vary from one implementation to another and from onedeveloper to another. Moreover, it will be appreciated that such adevelopment effort might be complex and time-consuming, but wouldnevertheless be a routine undertaking of engineering for those ofordinary skill in the art having the benefit of this disclosure.

In general, a variable stiffness surgical guidewire system for use witha flexible catheter, the system includes an elongated flexible guidewireand an actuator (also referred to as tool) selectively coupleable to theproximal end of the flexible guidewire for selectively controlling thestiffness of, at least, sections thereof. The system can be used in, forexample, medical techniques for treating systems including vascular,urinary, genital, gastro-intestinal, respiratory, biliary, andneurological systems. Preferably, the system may also include aremovable device to selectively maintain guidewire stiffness bymaintaining tension after removal of the tool.

FIG. 2A illustrates a guidewire 100 in accordance with an embodiment foruse during a surgical procedure. As shown in FIG. 2A, the guidewire 100is shown inside the aorta A of a patient, wherein the guidewire 100 isinserted through a proximal opening 12 of a catheter 14 and extends outof a distal opening or lumen 16 of the catheter 14. In contrast to theguidewire 10 in FIG. 1, the guidewire 100 in FIG. 2A includes a tensionwire 102 at its proximal end as well as tension head 104 which isexposed and may be manipulated by the user.

The tension head 104 is movable with respect to the body 106 of theguidewire 102. The guidewire 100 has a variable stiffness feature inwhich the stiffness of the guidewire 100 varies proportionally with thedistance between the tension head 104 and the coil body 106. Therefore,in operation, the stiffness a portion or all of the guidewire 100 willincrease as the tension head 104 is moved away from the body 106. Incontrast, movement of the tension head 104 in the opposite direction(toward the body 106) will cause the stiffness of the guidewire 100 todecrease. Maintaining the position of the tension head 104 with respectto the body 106 at a particular position will maintain the stiffness ofthe guidewire body 106. In particular, the construction of the guidewire100, as will be discussed in more detail below, allows the distal end ofthe guidewire 100 to remain stationary while the stiffness of theguidewire is increased.

FIG. 2B illustrates a perspective view of the proximal end of theguidewire 100 in accordance with an embodiment. As shown in FIG. 2B, theguidewire 100 includes a coil body 106, a tension wire 102 coupled tothe body 106 extendable out of the body 106, and a tension head 104coupled to the tension wire 102. In addition, the guidewire 100 is shownin FIG. 2B to preferably have a collar 108′ which represents a portionof the end of the coil body 104 that is closest to the tension head 104.

In an embodiment, the collar 108′ is formed by soldering and metalflowing together 3-5 windings of the coil at the proximal end of thecoil body wire 106. Thereafter, it is preferred that the soldered areais grounded and smoothed to create a smooth outer circular body with aflat collar end 108 which is perpendicular to the outer surface 108 ofthe collar in accordance with an embodiment. The guidewire 100 benefitsfrom construction of the collar 108′ as the collar 108′ serves toincrease the structural stability as well as the ability to bear tension(and resulting increased stiffness) enabled by soldering the end coilstogether. The collar 108′ also serves as a retaining wall which allowsthe windings of the guidewire to contract and press against one anotherwhen the stiffness of the guidewire 100 is increased. It should be notedthat soldering and metal flowing is one example of creating the collar108′ and that any other appropriate method is contemplated. It is alsocontemplated that the guidewire 100 not use a collar 108′ but some othermember which serves the functions of a retaining wall that allows thecoil windings of the guidewire 100 to contract press together when anincrease in stiffness of the guidewire 100 is desired.

FIG. 2C illustrates a side view of the distal end of the guidewire bodyin accordance with an embodiment. FIG. 2D illustrates an end view of thedistal end of the guidewire body in accordance with an embodiment. Asshown in FIGS. 2B and 2C, the tension wire 102 preferably is comprisedof one or more wires which are wound together to form a coiled or cabletype body, whereby the coils of the tension wire 102 are opposite to thecoils of the outer body 106. The tension wire 102 has a proximal end anda distal end, whereby the proximal end of the wire 102 is attached tothe tension head 104 as shown in FIG. 2B. In an embodiment, the tensionhead 104 is separately manufactured from the tension wire 102 such thatboth components are coupled to one another. In an embodiment, thetension wire 102 is formed with the tension head 104 being integrallyformed therewith.

The distal end of the tension wire 102 is attached to the distal end 109of the body 106 of the guidewire 100. As shown in FIGS. 2C and 2D, thedistal end of the wire 102 is positioned at the distal end 109′ of theguidewire 100, whereby the outer body 106 is preferably crimped tosecurely mount the tension wire 102 to the outer body 106. Inparticular, as shown in FIG. 2D, the crimped areas 111 force the body106 to apply a frictional force onto the tension wire 102, therebyallowing the wire 102 and the body 106 to withstand more tension forceduring stiffening of the guidewire 100 than previous soldering methods.Once the ends of wire 102 and outer body 106 are crimped, the distal end109 is preferably smoothed by known methods (e.g. soldering, machining)to form a smooth, rounded distal end 109 of the guidewire 100. In theembodiment shown in FIG. 2D, an 8-point micro-crimp style tool may beused to crimp the outer body 106 to the tension head 102, it should benoted that any other appropriate tool may be utilized.

As stated above, the coil windings of the tension wire 102 are oppositeto that of the outer body 106 of the guidewire 100. In an embodiment,the coil windings of the outer body 106 traverse clockwise along thelength of the body 106, whereas the coil windings of the tension wire102 traverse counterclockwise along the length of the wire 102, or viceversa. The opposite windings of the two members allow the distal end ofthe guidewire 100 to maintain its dimensional stability while theguidewire 100 is stiffened and under tension. Additionally, the opposedwindings allow the distal end of the guidewire 100 to maintain itslocation with respect to its proximal end while under tension. Further,the method of crimping the ends of the tension wire 102 and outer body106 allows tension to be applied-to and released-from the guidewire 100multiple times without crushing or damaging the outer body 106.Accordingly, the preferred design of the guidewire 100 discussed abovespecifically minimizes or avoids distal tip 109 deflection as well asany tendency for the distal portion of the guidewire 100 to straightenitself out with respect to the proximal end. By allowing the distalportion 109 to maintain its position while the guidewire 100 isstiffened, the user is provided the positional stability to deliver thenecessary surgical instruments and/or medicine to be delivered moreconsistently and accurately to the desired location within the patient.It should be noted that the other figures herein depicting the guidewire100 may not show the coiled tension wire 102 for clarity purposes.

An example of the construction for guidewire 100 is as follows: the body106 has an outer diameter of 0.035″×0.007″ of 304 sst wire×150 cm-300 cmlong coil body. Additionally, 5-10 coils located at the proximal end ofthe outer body 106 are soldered together and polished or grounded toform the collar 108′ and collar end 108. With the outer diameter of thecollar 108′ preferably having the same outer diameter as the outerdiameter of the coil body 106, and the inner diameter 103 of the collar108′ having a slightly larger diameter than the outer diameter of thetensioning wire 102, whereby the outer body 106 moves freely over thetension wire 102. One example of an acceptable tension wire 102 has a0.015″ outer diameter 304sst monofilament tension core which providesexcellent tensile strength (approximately 70 lbs.) and acceptablestiffness.

A preferred example of the tension wire 102 is a cable-braid wire whichprovides excellent tensional strength and stiffness and superiorpositional stability of the distal end of the guidewire 100 when undertension. In an embodiment, left hand or right hand wound coiled bodiesof the guidewire 100 are acceptable for use with left hand or right handtwist cables or monofilament core wires. The oppositely configured outercoil body and tension wire are such that the user experiences improvedtorsional stability when the guidewire 100 is tensioned to a desiredstiffness. This configuration may be more favorable than others forcertain applications requiring, namely, additional torsional strengthand dimensional stability during the procedures.

Referring back to FIG. 2B, the tension wire 102 and head 104 are shown adistance away from the collar 108 and body 106 in a default naturalstate. The guidewire 100 is designed such that the body 106 willincrease in stiffness as the head 104 (and wire 102) is further actuatedaway from the collar 108. In contrast, the body 106 will decrease instiffness as the tension head 104 (and wire 102) is moved toward thecollar 108 of the body 106.

As stated, it is preferred that the head 104 is positioned a certaindistance from the collar in a default nature state, whereby a portion ofthe wire 102 remains exposed outside the collar 108. Alternatively, thehead 104 abuts the collar 108 and the wire 102 is completely within thebody 106 when the guidewire 100 is in the default, natural state. Forpurposes of this description, it will be assumed that the head 104 ispositioned a certain distance from the collar 108 and a portion of thewire 102 is exposed, as shown in FIG. 2B, when the guidewire 100 is atits default natural state.

As shown in FIG. 2A, the body 106 has a diameter D, whereby the tensionwire 102 has a diameter d_(w), and the tension head 104 has a widthdimension w_(h). The diameter d_(w) of the tension wire 102 ispreferably smaller than the diameter D of the body 106. Additionally, itis preferred that the width w_(h) of the tension head 104 is greaterthan the diameter d_(w) of the tension wire 102 but preferably smallerthan the diameter D of the body 106. Considering that the inner diameterof the instrument or drug carrying catheter is slightly larger than thediameter D of the body, a smaller width dimension w_(h) of the tensionhead 104 will ensure that the medical instruments and drug may be loadedor unloaded directly over the head 104 of the guidewire 100 withoutproblems or resistance.

It should be noted that the tension head 104 is shown in FIG. 2B to havea triangular shape. Although this is a preferred shape, the tension head104 may alternatively have any other shape including, but not limitedto, square, hexagonal, pentagonal, trapezoidal, spherical, circular,etc. Considering that the head 104 is shown as triangular in theembodiment in FIG. 2A, the width dimension w_(h) is the length of alongest side (or any side if the head 104 is an equilateral triangle).In an embodiment that the head 104 is another shape, the width dimensionw_(h) is preferably the length of the longest side of the shape.

FIG. 3A illustrates a diagram of a guidewire tensioning tool inaccordance with an embodiment. As shown in FIG. 3A, the tool 200includes a body having a first portion 202A and a second portion 202B,whereby each portion has a pair of respective jaws 204A, 204B and a pairof respective handles 206A, 206B coupled to one another at a fulcrum208. A spring-like member 210 is preferably coupled to both sides 202A,202B. The spring-like member 210 preferably applies an inwardly directedforce F_(s) (as shown by the arrows) which urges the handles 206A, 206Bto move toward each other and thereby urging the jaws 204A, 202B to moveapart from one another by default. It should be noted that although aregular spring 210 is shown in the Figures of the tool 200, it iscontemplated that any type of resilient material may be used insubstitution to a typical spring, including but not limited to, a leafspring, foam, elastics, etc.

The jaws 204A, 204B are configured to receive and engage the tensionhead 104 of the guidewire 100. In particular, controlled movement of thejaws 204A, 204B toward or away from one another will result in thecorresponding stiffness or flaccidness of the guidewire body 106. Aswill be discussed, the jaw 204B preferably includes a guidewireengagement feature which allows the jaw to engage the tension head 104during operation. Some example embodiments of the guidewire engagementfeature will now be described in FIGS. 4A-4D.

FIG. 4A illustrates a detailed view of the guidewire engagement featurein accordance with an embodiment. As shown in FIG. 4A, the tool 200 hasjaws 204A and 204B, whereby jaw 204A will be referred to as the distaljaw 204A and jaw 204B will be referred to as the proximal jaw 204B. Thedistal jaw 204A shown in FIG. 4A has an open fork aperture 218 whichallows the wire 102 to vertically slip downward into the aperture 218from the top surface of the jaw 204A. In an embodiment, the jaw 204A hasa flanged portion 207 is maintains the position of the collar 108 andprevents it from moving vertically upward the top surface of the jaw204A and disengaging from the jaw 204A. The aperture's 218cross-sectional dimension is preferably smaller than the diameter of thecollar 108 such that the collar 108 remains to the outside surface 220of the distal jaw 204A. In an embodiment, the cross sectional dimensionof the aperture 218 is constant from the outside surface 220 to theinside surface 222 of the distal jaw 204A. In an embodiment, as shown inFIG. 4D, the cross sectional dimension of the aperture 218 is notconstant from the outside surface 220 to the inside surface 222, butinstead has a recessed portion 224 which allows the collar to sit withina portion of the distal jaw 204A. In an embodiment, the aperture 218 hasa tapered shape in which the size of the aperture is larger near theoutside surface 220 than the inside surface 222.

FIGS. 4B and 4C illustrate different types of jaw configurations. InFIG. 4B, the proximal jaw 204B has a open-ended fork arrangement, suchas a pliers beak, as with the distal jaw 204A. The flange 205′ of theproximal jaw 204B prevents the head 104 from vertically running upwardand disengaging from the jaw 204B. FIG. 4C illustrates the distal jawhaving a tapered flange 207′ design which also maintains the collar 108again the outer surface of the jaw 204A.

Additionally, the proximal jaw 204B preferably includes an engagingaperture 230 therethrough which has a cross-sectional dimension largeenough to allow the tension head 104 to extend through, whereby thetension head 104 engages the outer surface 228 when inserted through theengaging aperture 230 from the inner surface 226 to the outer surface228. However, once the tension head 104 passes through the engagingaperture 230, the aperture 230 is selectively engaged with the tool 220,whereby the head 104 is unable to pass through the aperture 230 backtoward the collar body 108 until desired by the user.

FIGS. 5A-5C illustrates perspective views of the guidewire engagingfeature of the tool 200 in accordance with an embodiment. It should benoted that although the engaging feature is described within the contextof the tool 200, the engaging feature may be incorporated in any otherof other devices described herein (e.g. tools 1200, 1400, 1500 discussedbelow). As stated above, the tension head 104 preferably has atriangular shape in an embodiment. Similarly, in an embodiment, theengaging aperture 230 has a similar triangular shaped passage throughthe entire thickness of the proximal jaw 204B and/or the distal jaw204A, as shown by the phantom lines in FIG. 5A. In FIG. 5A, thetriangular head 104 is shown passing through the aperture 230 from theinner surface 226 to the outer surface 228 of the jaw 204B, whereby theshape of the head 104 is in communication and registers with thecorresponding shape of the aperture 230. As such, the dimensions of theaperture 230 are at least slightly larger than the dimensions of thehead 104 to allow the head 104 to traverse through the aperture 230. InFIG. 5B, the head 104 traverses entirely through the aperture 230 and isrotated about axis A, as shown by the arrows, to allow the head 104 tobe engaged with a tool 200, 1200 as discussed below. In an embodiment,the head 104 does not rotate, but instead the jaw 204B is rotated tobring the combination to the configuration in FIG. 5C.

In FIG. 5C, the head 104 is rotated 60 degrees out of alignment with theaperture 230, whereby the head 104 is then urged into frictional contactwith the outer surface 228 of the jaw 204B by the guidewire body 106. Bybeing in frictional contact with the outer surface 228 of the jaw 204B,the head 104 is thereby engaged and in a locked position with the jaw204B. To unlock and disengage the head 104 from the tool 200, the head104 is rotated 60 degrees about axis A until it is aligned with theaperture 230, as shown in FIG. 5A.

FIG. 6A illustrates a perspective view of the guidewire engaging featureof the tool 200 in accordance with an embodiment. It should be notedthat although the engaging feature is described within the context ofthe tool 200, the engaging feature may be incorporated in any of theother devices described herein (e.g. tools 1200, 1400, 1500). In anembodiment, the aperture 230′ includes a recessed portion 232 which is60 degrees out of alignment with the aperture 230′ such that the head104 is securely seated within the recessed portion 232 when in thelocked and engaged position. The recessed portion 232 secures the head104 and prevents the head 104 from unintentionally rotating when engagedby the jaw 204B′ or any of the other devices described herein (e.g.tools 1200, 1400, 1500). FIG. 6B illustrates a cross sectional view ofthe aperture 230′ along section B-B in accordance with an embodiment.

FIG. 6C illustrates an alternate cross sectional view of the aperture232′ in which the recess tapers outward toward the outer surface 230′.In the embodiment in FIG. 6C, the rounded tapered shaped recess 232′facilitates easier interfacing and engaging as well as disengaging ofthe triangular head 104 from the aperture 232′.

Once the head 104 is engaged and in a locked position with the tool 200,the guidewire 100 is then able to be manipulated using the tool.Referring back to the tool embodiment shown in FIG. 3A, the tool 200includes a stiffness adjustment mechanism 212 which serves to provide anequal and opposing force to the spring 210 to stabilize mechanicalmovement of the jaws 204A, 204B. The embodiment of the adjustmentmechanism 212 shown in FIG. 3A comprises a nut 216 and one or more bolts214A, 214B which are coupled to the tool 200 in the embodiment shown inFIG. 3A. The adjustment mechanism 212 operates by rotation of one orboth of the nuts 214A, 214B in predetermined directions which therebycauses the bolt 216 to move transversely in the desired direction (asshown by the arrow). For example, rotation of the nut 214A and/or 214Bin a predetermined direction will cause the nut 216 to move toward thefulcrum 208 and eventually abuts the middle body 218 of the tool 200.Considering that the spring like member 210 urges the handles 206A, 206Btoward one another (and thus the jaws 204A, 204B away from each other),the bolt 216, upon applying a counter force to the middle body 218, willcause handles 206A and 206B to move away from one another and ultimatelyforce the jaws 204A, 204B of the tool to move closer to one another.Considering that the stiffness of the engaged guidewire 100 increases asthe jaws 204A, 204B are moved apart from one another, the adjustmentmechanism 212, by default or when not in use, presses against the middlebody 218 and causes the handles 206A, 206B to be apart from one anothera maximum allowable distance. This allows the tool 200 to allow easymanipulation of the guidewire 100. FIG. 3B illustrates the preferreddefault position of the tool 200 in accordance with an embodiment.

In operation, upon the head 104 of the guidewire 100 being engaged bythe tool 200, the user is able to manipulate the adjustment mechanism212 by pressing the handles 206A, 206B toward each other and therebymoving the jaws 204A, 204B away from one another. The gradual movementof the jaw 204B away from jaw 204A forces the tension head 104 away fromthe collar 108 and thus gradually increases the stiffness of theguidewire 100 to a desired amount. In an embodiment, the tool 200 mayinclude a caliper type measuring feature which allows the user to knowthe amount of stiffness the guidewire 100 is undergoing based on themeasured distance between the jaws 204A, 204B (FIG. 10).

FIG. 7 illustrates a diagram of a tool in accordance with an embodiment.As shown in FIG. 7, the tool 300 is similar in design and operation tothe tool 200 described in FIGS. 3A and 3B. In contrast to the tool 200,the tool 300 includes a hard stop mechanism 312 configured to provideone or more fixed stops, whereby each stop represents a predetermineddistance between jaws 304A and 304B. The stop 312 shown in FIG. 7 ispreferably fixed and defines the maximum distance (and thus maximumstiffness in the guidewire 100) which jaws 304A, 304B may be apart fromone another when the tension head 104 is engaged thereto. In operation,middle body 318 is shaped such that it comes into contact with the stop312 and thus does not allow handles 302A, 302B to be pressed toward oneanother any further. In operation, the hard stop mechanism 312 allowsthe guidewire 100 to achieve three levels of stiffness: soft or nostiffness when the guidewire 100 is not engaged to the tool 300,intermediate stiffness when the guidewire 100 is engaged to the tool 300but the handles 302A, 302B are not pressed together, and maximumstiffness when the guidewire 100 is engaged to the tool 300 and themiddle body 318 is pressing against the hard stop 312.

FIG. 8 illustrates a diagram of a tool in accordance with an embodiment.As shown in FIG. 8, the tool 400 is similar in design and operation tothe tool 200 described in FIGS. 3A and 3B. In contrast to the tool 200in FIGS. 3A and 3B, the tool 400 includes an adjustment mechanism 412having a cam 414 configured to rotate about a cam axle 416 and whichincludes one or more cam surfaces 418 which bear against the middle body420 to move the jaws 404A, 404B toward or away from each other apredetermined distance. In particular, the cam 414 shown in FIG. 8includes three cam surfaces 418A, 418B, and 418C, the cam surfaceshaving respective radii, r₁, r₂, r₃ with respect to the cam axle 416. Itshould be noted that any number of cam surfaces 418, including just one,is contemplated. In the embodiment shown in FIG. 8, the three radii ofthe cam surfaces 418A, 418B, and 418C are related as follows: distanceof r₁ to axle <distance of r₂ to axle <distance of r₃ to axle.Considering that the spring 410 urges the handles 402A and 404B towardone another, the cam 414 applies a force to the middle body whichopposes the spring force F_(S). Thus, if the cam 414 is actuated suchthat cam surface 418A having the largest radius, r₃, is in contact withthe middle body, the cam 414 will force the handles 402A, 402B to moveaway from one another the greatest distance. This results in the jaws404A, 404B being moved toward each other. In contrast, as the cam 414 isactuated to a position where the cam surface 418A having the smallest ofthe available radii, r₁, is in contact with the middle body, the cam 414will force the handles 402A, 402B to move toward one another. Thisresults in the jaws 404A, 404B moving away from one another tool 400,thereby effectively increasing the stiffness in the guidewire 100.

FIG. 9 illustrates a diagram of a tool in accordance with an embodiment.As shown in FIG. 9, the tool 500 is similar in design and operation tothe tool 200 described in FIGS. 3A and 3B. In contrast to the tool 200in FIGS. 3A and 3B, the tool 500 includes an adjustment mechanism 512having a detent assembly which functions, somewhat analogously to atorque wrench, for allowing the selection of maximum applied tension.The detent setting may be set to a specific force (much like a torquewrench) such that once the designated force to the tool handle exceedsthe desired level, the detent mechanism 512 activates and preventsfurther tensioning of the guidewire. The detent mechanism 512 thus canact as a form of a “safety” against over tensioning the guidewire.

FIG. 11 illustrates a perspective view of a guidewire insert orcartridge in accordance with an embodiment. As shown in FIG. 11, thecartridge (also referred to herein as an insert) 600 is positionedbetween the head 104 and the collar 108 of the guidewire body 106,whereby the cartridge 600 maintains the stiffness in the guidewire 100by maintaining the head 104 at a desired distance from the collar 108.In particular, the cartridge 600 has a cylindrical body having aproximal end 602 which abuts an inner surface 105 of the guidewire head104 and a distal end 604 which abuts the guidewire's collar 108. Inaddition, the cartridge 600 has an inner diameter 606 substantiallyequal or slightly larger than the diameter of the guidewire's tensionwire 102. The cross-section of the cartridge is preferably in the shapeof a trapezoid as shown in FIG. 11, although other shapes arecontemplated (e.g. C-shaped, square, triangular, etc.) With regard tothe embodiment in FIG. 11, the trapezoidal cross-section of thecartridge produces two opposing sides 603 as well as two adjacent faces601. The opposing sides 603 allow the cartridge to be easily grasped byan engagement tool (discussed below) whereas the adjacent faces 601allow the cartridge to be easily disengaged by the disengaging tool(discussed below). The adjacent faces 601 preferably encompass 210degrees of the wire 102, although other angles are contemplated. Thisconfiguration (shown in FIGS. 20-22B) allows the disengaging tool topush the faces 601 downward to slightly increase the diameter 606 of thecartridge 600 to disengage the cartridge 600 from the tension wire 102.

The cartridge 600 may be constructed of a durable, rigid, yet slightlyflexible material having a high longitudinal compressive strength (e.g.Lexan, Plexiglas, Lucite, Perspex) so that the cartridge 600 can flexopen and snap into circumferential position over the core wire 102 andlater spring open when it is pushed “away” from the core wire 102 so asto permit removal of the cartridge 600.

It is preferred that the cartridge 600 is smaller than or equal to thediameter of the guidewire's body 106 as well as the cross section of thelumen of the instrument or drug carrying catheters with which theguidewire 100 operates. Accordingly, the cartridge 600 allows the userthe freedom to load, unload, advance and retract surgical devices overthe proximal end of the guidewire and cartridge 600 while the desiredstiffness of the guidewire 100 is maintained without compromising thestiffness of the guidewire 100 and without removing the cartridge 600.Thus, the configuration and dimensions of the cartridge 600 allows thetension of the guidewire 100 to be maintained while the exchange ofcatheters, balloons, stents and/or other surgical tools and medicine mayoccur over the guidewire 100 without having to remove the cartridge 600or exchange guidewires.

FIGS. 12 and 13A-13D illustrate perspective views of a selectivelyopenable guidewire insert 800 in accordance with an embodiment. Asshown, the insert 800 is positioned between the head 104 and the collar108 of the guidewire body 106, whereby the insert 800 maintains thestiffness in the guidewire 100 by maintaining the head 104 at a desireddistance (and desired tension) from the collar 108. In particular, theinsert 800 has a cylindrical body having a proximal end 808 which abutsthe guidewire head 104 and a distal end 810 which abuts the guidewire'scollar 108 when the insert 800 is coupled to the tension wire 102. Inaddition, as shown in FIG. 13A, the insert 800 has an inner diameter 812as well as an outer diameter 814, whereby the inner diameter 812 issubstantially equal or slightly larger than the diameter of theguidewire's tension wire 102. It is preferred that the outer diameter814 of the insert 800 is smaller than or equal to the diameter of theguidewire's body 106. Further, it is preferred that the overall outerdiameter of the insert 800 is smaller in cross section than the lumen ofthe surgical components with which the guidewire 100 operates.Accordingly, the insert 800 allows the user the freedom to load, unload,advance and retract surgical devices over the proximal end of theguidewire and insert 800 while the desired stiffness of the guidewire100 is maintained.

As shown in FIG. 12, the insert 800 has a clam-shell configurationhaving a lower portion 802 and an upper portion 804 coupled to oneanother at a hinge 806. The hinge 806 may be created as an integralscore in the insert's 800 material. This configuration allows the insert800 to be applied over the extended wire 102 in an open position (asshown in FIG. 12) and then actuated or snapped to a locked position byclosing the clam shell configuration around the extended wire 102. Thematerial of the insert 800 is durable and rigid to force the head 104from the collar 108 and thus maintain stiffness in the guidewire 100.

In operation, after the tool 200 moves the head 104 a desired distancewith respect to the collar 108 to achieve the desired amount ofstiffness, the clamshell-like insert 800 is applied and secured aroundthe tension wire 102 to maintain the increased guidewire stiffness afterthe tool 200 is removed. As discussed below, the upper and lowerportions of the insert 800 may be completely separated from one anotherprior to and/or after the insert 800 is coupled to the tension wire 102.

FIG. 13A illustrates the clamshell insert 800 having a snap-fitconfiguration in which the upper portion 804 includes one or more maleprotrusions 818 and the lower portion 802 includes one or more femalereceivers 816 which receive the male protrusions 818 to lock the insert800 in the closed position. It should be noted that the snap-fitconfiguration shown in FIG. 13A is an example only and other appropriatelocking mechanisms are contemplated. For example, the lower and upperportions 802, 804 may be maintained in the closed position by magnets,screws, etc. In addition, the insert 800 may be made of any appropriatematerial which maintains the head 104 at the desired distance from thecollar 108. For example, the insert 800 may be made of durable plastic,stainless steel, aluminum, composite alloys, etc. Inserts 800 ofdifferent length may be provided to sustain various amounts of stiffnessin the guidewire 100. In an embodiment, the insert 800 may be stamped tohave stiffness information on its outer surface to easily inform theuser as to how much tension the guidewire 100 will experience upon theinsert 800 being applied thereto. In an embodiment, the insert 800 maybe disposable and of one-time use, although the insert 800 mayalternatively be reused. It should be noted that the above-describeddesign of the insert 800 facilitates fast, simple placement and removal.

FIG. 13B illustrates an embodiment in that the insert 800 is shownalmost closed over the tension wire 102. As shown in FIG. 13B, theinsert 800 includes an opening 820 along which extends from one end tothe opposite end of the body, whereby the opening remains even after theinsert 800 is actuated to the closed position. The opening 820 allows acorresponding tool to remove the insert from the tension wire 104 bypulling the portions adjacent to the opening 820 apart enough toincrease the width of the opening 820. Upon width of the opening 820being large enough, the insert 800 will then be able to be easilyremoved from tension wire 102. This allows the user to quickly removethe insert 800 to adjust the stiffness of the guidewire 100. It shouldbe noted that the above-described design of the insert 800 facilitatesfast, simple placement and removal.

FIG. 13D illustrates a perspective view of a guidewire with combinablecartridges in accordance with an embodiment. As shown in FIG. 13D, theguidewire 100 includes an index groove 110 located on the collar 108. Inaddition, the tension head 104 is shown to include an index ridge 112,whereby the ridge 112 is configured to fit completely into index groove110 when the tension head 104 abuts the collar 108 when the guidewire100 is in a relaxes natural state.

In the embodiment in FIG. 13D, one or more cartridges 822 are showncoupled to the guidewire 100 whereby the cartridges are shownconsecutively linked to one another to maintain a specified tension inthe guidewire 100. In particular, cartridge to 822A and cartridge 822Bare coupled to one another and positioned end to end between the tensionhead 104 and the collar 108 of the guidewire 100. As shown in FIG. 13D,cartridge 822A includes a cartridge groove or detent 824A on the endproximal to the tension head 104 and a cartridge ridge or protrusion826A on the opposite end. Similarly, cartridge 822B includes a cartridgegroove 824B on the end which abuts the cartridge ridge 826A of cartridge822A and a cartridge ridge 826B on its opposite end, whereby thecartridge ridge 826B fits within the index groove 110 of the guidewire100. It should be noted that the index ridge 112 and index groove 110 ofthe guidewire 100 are not required to utilize the consecutive cartridgeshaving the indexed ridges and grooves. It should also be noted thatalthough two cartridges you shown in FIG. 13D, any number of cartridgesmay be used with the guidewire. It is also contemplated that anycartridge may have the same features (ridges and/or grooves) on bothends. It should also be noted that the groove and/or ridge features maybe applied to any of the other inserts discussed herein and is notlimited to only the figures which show them.

Cartridges 822A, 822B each have a length dimension such that theguidewire 100 will undergo a certain amount of stiffness when only onecartridge is used. However, as shown in FIG. 13D, the guidewire 100 willundergo additional stiffness when both cartridges are combined seriallyand placed over the tension wire 102 of the guidewire 100. This allowsthe user to variably adjust the amount of stiffness desired on theguidewire 100 by adding or removing cartridges 822 during the procedure.In an embodiment, the cartridges are of equal length, although thecartridges may be of varying lengths in an embodiment. In an embodiment,each cartridge may be marked, or color-coded, with a value whichrepresents the amount of tension which the guidewire 100 would undergowhen that particular cartridge is coupled to the guidewire 100. In afurther embodiment, these values may be combined to provide a combinedtension value which represents the amount of tension which the guidewire100 would undergo when those combined cartridges are coupled to theguidewire 100. As with the other cartridges described herein, thecartridges in FIG. 13D preferably have an outer diameter smaller than orequal to the outer diameter of the guidewire body 106 to allow ease ofloading and unloading of instrument and drug catheters withoutcompromising stiffness in the guidewire 100.

FIG. 14 illustrates a perspective view of an insert placement tool inaccordance with an embodiment. As stated above, the upper and lowerportions of the insert 800 (FIG. 12) may be completely separated fromone another prior to and/or after the insert 800 is coupled to thetension wire 102. In other words, the upper 804 and lower portions 802of the insert 800 (FIG. 12) may be separate pieces which are notattached at a moveable hinge, but instead include an attachment meanswhich allow the portions 802, 804 to be attached together when coupledto the tension wire 102 and completely disattached from one another whennot coupled to the tension wire 102. Such an attachment means may besnap features, magnets, screws, tacks, etc.

In FIG. 14, the insert placement tool 900 is utilized to couple and/orremove the upper and lower portions 804, 802 with respect to the tensionwire 102. The tool 900 includes an upper clasp 902 and a lower clasp 904which are moveable with respect to one another about the joint 906. Apair of handles 908A, 908B are coupled to the joint 906 and are moveableto selectively operate the clasps 902, 904 to move toward and away fromone another.

In an embodiment, the claspers 902, 904 have a length dimension which issmaller than the length of the upper and lower portions 802, 804 of theinsert 800. This allows the claspers 902, 904 to be placed between thejaws 204A, 204B of the extender tool 200 (FIG. 3A) to deliver the insert800 to the tension wire 102 while the head 104 is extended away from theguidewire's collar 108. Once the claspers 902, 904 are placed over thetension wire 102, the user preferably actuate the handles 908A, 908Btoward one another to couple the upper and lower portions 802, 804 ofthe cartridge 800 to one another and around the tension wire 102. Theinsertion tool 900 thereby “snaps” the insert 800 over the tension wire102 and the tool 900 is then removed from between the tool's jaws. In anembodiment, the clapsers 902, 904 do not deliver the insert 800, butinstead are themselves placed between the tension head 104 and thecollar 108 to maintain the stiffness of the guidewire after the tool 200is removed.

FIG. 15 illustrates a perspective view of self-maintaining guidewire1000 in accordance with an embodiment. As shown in FIG. 15, theguidewire 1000 includes an aperture 1010 (shown in phantom lines)through the tension wire 1002. Although only one aperture 1010 is shownin FIG. 15, any number of apertures 1010 may be configured along thetension wire 1002. The aperture 1010 is configured to receive a settingpin 1012 therethrough, whereby the guidewire 1000 is able to maintainthe desired stiffness when the setting pin 1012, inserted in the desiredaperture 1010, abuts the collar 1008. It is preferred that apertures1010 are configured in a spaced fashion such that the pin 1012 may beinserted into any of the available apertures 1010 which correspond tothe desired stiffness which the user wants the guidewire 1000 toachieve.

FIG. 16 illustrates a perspective view of self-maintaining guidewire1100 in accordance with an embodiment. As shown in FIG. 16, theguidewire 1100 includes a foot 1110 which is configured within acorresponding recess 1112 within the tension wire 100. The foot 1110 ispreferably urged upward away from the wire 1102 by a spring 1114, suchthat the foot 1110 “pops out” when it is extended out from within thebody 1106 past the collar 1108. In operation, once the tension wire 1102is extended far enough from the guidewire body 1106, the foot 1100springs out from the recess 1112 and abuts the collar 1108 to maintainthe position and tension of the guidewire 1100. In an embodiment, thetension wire 1102 can be retracted and the guidewire relaxed by pressingthe foot 1100 back into the recess 1112 using a tool (e.g. hemostat) andallowing the tension head 1104 to retreat back toward the defaultposition.

FIG. 17A illustrates a side view of a combined tensioning and insertapplicator tool in accordance with an embodiment. In particular, thetool 1200 includes a handle member 1202, a trigger member 1204, anelongated tray 1206, a collar interface 1210, and a tension brace 1212.In an embodiment, the handle member 1202 is designed to have a pistolgrip and an elongated trigger member as shown in FIG. 17A, however anyother appropriate shape for the handle 1202 and trigger member 1204 iscontemplated.

A proximal end 1208 of the elongated tray 1206 is mechanically andoperably coupled to the handle 1202 and the trigger 1204. The distal endof the tray 1206 terminates with a collar interface 1210 which isconfigured to abut the collar 108 of the guidewire body 106 when thetool 1200 is in operation. The collar interface 1210 preferably includesa notch 1216 (FIG. 18) through which the tension wire 102 passes whilethe tool 1200 is operating with the guidewire 100. The elongated tray1206 in the embodiment shown in FIG. 17A has an open top in which thetension brace 1212 is exposed. This embodiment allows the user to viewthe tensioning of the guidewire and as well as movement of the tensionbrace 1212 along the elongated tray 1206.

In contrast, FIG. 17B illustrates an elongated barrel tray 1206′ whichit is closed, whereby the interior of the tray cannot be viewed by theuser 1206′. As shown in FIG. 17B, the barrel tray 1206′ has a notchfeature 1216′, preferably triangular in cross-section, on its distal endwhich receives the tension wire as well as the tension head and throughwhich the tension wire 102 passes while the tool is operating with theguidewire 100.

The tool 1200 shown in the embodiment in FIG. 17A also includes atension brace 1212 which is adjustably moveable along the elongated tray1206 between the tray's 1206 proximal and distal ends 1208, 1210. Inparticular, the tension brace 1212 is configured to retract toward theproximal end 1208 as the trigger 1204 is squeezed. In an embodiment, thetension brace 1212 freely moves along the tray 1206 in response toactuation of the trigger 1204. In an embodiment, the tension brace 1212is urged toward the distal end 1210 by spring 1215. In this embodiment,a rod 1217 is coupled at one end to a rotating cam of the trigger 1204and another end is coupled to the brace 1212, whereby actuation of thetrigger 1204 overcomes the forces on the tension brace 1212 by thespring 1215 to move the tension brace 1212 toward the proximal end 1208.

In an embodiment, the notch feature 1216 is configured to receive aportion of the tension wire 102 therethrough along with the tension head104 when the tension brace 1212. The tension brace 1212 is preferablypositioned proximal to the collar rest 1210 and has a tension head 104engaging aperture. In an embodiment, the tension brace 1212 has the headengaging aperture as described above in FIG. 5A-5C or 6A-6C, and thedetails of the engaging apertures are not discussed again herein. Itshould be noted that other configurations of head engaging apertures arecontemplated.

In the embodiment in FIG. 17A, the tool 1200 includes a magazine 1214configured to house one or more of the cartridge inserts describedabove. The magazine 1214 is shown preferably coupled to and positionedbelow the elongated tray 1206, although it is contemplated that themagazine may be positioned above or to the side of the elongated tray1206. FIG. 20 illustrates an broken view of an interior of the cartridgemagazine 1214 in accordance with an embodiment. In general, thecartridge magazine 1214 preferably houses the cartridge prior tocoupling the cartridge to the tension wire 102 of the guidewire 100. Inan embodiment, the cartridge magazine 1214 additionally or alternatelyretrieves and stores the cartridge after the cartridge has been coupledto the tension wire 102. As shown in FIG. 19, the magazine 1214preferably includes a lifter mechanism 1220 positioned within themagazine 1214 along with a cartridge inserter 1222 which is coupled tothe lifter mechanism 1220.

As shown in FIGS. 19-21, the lifter mechanism 1220 preferably comprisesone or more sets of scissor members 1228 which are coupled to oneanother about an axis, whereby each scissor member 1228 includes aroller 1232 on its end. The scissor members 1228 preferably move along areceiving groove along the bottom surface 1234 of the magazine 1214 suchthat the rollers 1232 move along only one dimension within the magazine1214. Alternatively, the scissor members 1228 move along a smoothsurface within the bottom surface 1234 of the magazine 1214. Inoperation, the rollers 1232 move along the bottom surface 1234 towardone another to cause the lifter mechanism to move upward toward the tray1206. In an embodiment, the lifter mechanism 1220 preferably urges thecartridge inserter 1222 to move in an upward direction by the use of aspring. In another embodiment, a separate actuating control (not shown)external to the magazine 1214 is used to selectively cause the liftermechanism 1220 to move upward and/or downward with respect to the tray1206. Such an actuating control may be a mechanical and/or electronicswitch, lever, button or other actuating means. In an embodiment, themagazine 1214 is capable of easily being disengaged from the tool 1200.This allows the magazine 1214 to be reloaded with one or morecartridges, or be replaced with an already full magazine which is thencoupled to the tool 1200.

As shown in FIGS. 20 and 21, the cartridge inserter 1222 has a U-shapedconfiguration, whereby angled ends of the inserter 1222 preferably comeinto contact the sides 603 of the cartridge 600 (See FIG. 11) and allowthe inserter 1222 to securely hold and move the cartridge 600 to engagethe wire 102. The magazine 1214 is preferably positioned underneath theelongated tray 1206, whereby the tray 1206 includes an aperture 1226 incommunication with the interior of the magazine 1214 as shown in FIG.20. In an embodiment, the aperture 1226 has a length dimension along theelongated tray 1206 to allow specific sized cartridges to passtherethrough. In an embodiment, the aperture 1226 has a length dimensionwhich traverses the entire length of the elongated tray 1206 to allowany sized cartridges to pass therethrough. The aperture 1226 allows thecartridge 800 to be deployed within the magazine in an upward directionto come in contact with and couple to the tension wire 102 as thetension wire 102 is extended by the tension brace 1212. In anembodiment, the aperture 1226 constantly remains open in the elongatedtray 1206. In an embodiment, the aperture 1226 has a door whichselectively opens to allow the cartridge to be deployed around thetension wire 102.

In operation, as shown in FIG. 20, the user operates the tool 1200 byplacing the collar rest 1210 against the collar 108 of the guidewire100. The tensioning head 104 is inserted through the notch feature 1216and is then engaged and locked with the tension brace 1212. The tensionbrace 1212 may have any of the engaging apertures described above. Theuser then gradually applies force to the trigger 1204 to cause thetension brace 1212 to gradually move from the collar rest 1210 towardthe handle 1202. As the tension brace 1212 moves toward the proximal endof the tray 1206 the tensioning wire 102 extends and thus causes theguidewire to increase in stiffness. Once the tension brace 1212 movesaway from the aperture 1226 a desired distance, the lifter mechanism1220 preferably automatically actuates to cause the scissor members 1228to move toward one another and cause the cartridge holder 1222 as wellas a cartridge 600 to move upward through the aperture 1226 and aroundthe tension wire 102. In an embodiment, the user operates a separateactuator mechanism to cause the lifter mechanism 1220 to operate.Preferably, the quick upward movement of the inserter 1222 and cartridge600 causes the cartridge 600 to snap around the tension wire 102, asshown in FIG. 21.

As stated above, the cartridge 600, once deployed, will maintain thetension of the guidewire. This allows the user to depress the trigger,which causes the tension brace 1212 to move back toward the distal endof the elongated tray 1206 and abut the end of the cartridge 600. Thetension head 104 is then disengaged from the tension brace 1212. Thetool 1200 is then preferably removed from the guidewire 100 to allowsurgical tools and/or drugs to be delivered along the tensionedguidewire via the guidewire's proximal end.

FIG. 22A illustrates a side view of a combined tensioning as well as ancartridge applicator and removal tool in accordance with an embodiment.As with the tool discussed in FIGS. 17-21, the tool 1300 includes ahandle member 1302, a trigger member 1304, a closed, barrel-shapedelongated tray 1306, a collar interface 1310, and a tension brace 1312.As with the embodiment in FIG. 17A, the handle member 1302 is designedto have a pistol grip and an elongated trigger member 1304, although anyother appropriate shape for the handle 1302 and trigger member 1304 iscontemplated.

As with the embodiment in FIG. 17A, the tool 1300 includes a magazine1314 positioned below the barrel tray 1306 and is configured to deploy acartridge around the tension wire 102 of the guidewire 100 when thetension head 104 is extended a desired distance from the collarinterface 1310. As with the embodiment in FIG. 17A, the barrel tray 1306may include an aperture in its bottom surface which is in communicationwith the interior of the magazine 1314. As stated above, the magazine1314, upon actuation, moves the cartridge 600 upwards through theaperture in the bottom surface of the barrel tray 1306. Upon thecartridge 600 coming in contact with the tension wire 102, the cartridge600 couples to the tension wire 102 to prevent the tension wire 102 fromreverting back to the collar 108 or the relaxed default position of theguidewire 100.

In the embodiment in FIG. 22A, the tool 1300 also includes a removalmagazine 1316 preferably positioned above the barrel tray 1306. Theremoval magazine 1316 houses a removal mechanism that is configured toremove an already deployed cartridge 600 from the tension wire 102 whenthe cartridge 600 is no longer needed. In an embodiment, the removalmagazine 1316 is in communication with an aperture in the top surface ofthe barrel tray 1306 to allow the cartridge 600 to be removed from thetray 1306 and moved into the removal magazine 1316.

In the embodiment in FIG. 22A, the lifter mechanism 1318 preferablycomprises one or more sets of scissor members 1320 which are coupled toone another about an axis. In an embodiment, each scissor member 1320includes a roller 1322 on its end. The scissor members 1320 preferablymove along a receiving groove along the top surface 1324 of the magazine1316 such that the rollers 1322 move along only one dimension within themagazine 1316. Alternatively, the scissor members 1320 move along asmooth surface of the top surface 1324 of the magazine 1316. Inoperation, the rollers 1322 move toward one another to cause the liftermechanism to move downward toward the barrel tray 1306. In anembodiment, the removal mechanism 1318 preferably urges the cartridgeremover 1326 to move in a downward direction via a spring. In anotherembodiment, a separate actuating control (not shown) external to themagazine 1316 is used to selectively operate the removal mechanism 1318when the user desires. Such an actuating control may be a mechanicaland/or electronic switch, lever, button or other actuating means.

FIG. 22B illustrates an end view of the tool 1300 with removal mechanism1318 in accordance with an embodiment. The insert magazine 1314 is notshown in FIG. 22B for clarity purposes. In an embodiment, the cartridgeremover 1326 has a similar cross-sectional shape to the inserter 1222shown in FIGS. 20 and 21 in which the remover 1326 has a U-shapedconfiguration with angled ends. The ends of the remover 1326 come intocontact with the slightly angled faces 601 of cartridge 600, whereby thepointed ends press against the faces 601, as shown in FIG. 22B. As theends of the remover 1326 press against the faces 601, the forces causethe faces 601 to the bend downward and outward with respect to theaperture 606. Upon sufficient force being applied to the faces 601, themovement of the faces 601 away from one another causes the diameter ofthe aperture 606 to slightly increase, thereby allowing the cartridge600 to slip off of the tension wire 102, thereby disengaging thecartridge 600 from the wire 102.

It should be noted that although an example is shown and described as tothe construction of the removal mechanism, any appropriate constructionwhich allows the cartridge remover 1326 to move to the barrel tray 1306and remove the cartridge 800 is contemplated. It should be noted thatalthough the figure shows two separate magazines, one for insertion andone for removal of the cartridge, is contemplated that one magazine maybe used to perform both insertion and removal functions in anembodiment. It should also be noted that although the cartridge 600 isdiscussed in relation with the embodiments in FIGS. 19-22B, any othershaped cartridge may be used as a substitute with appropriately modifiedinserter and/or remover devices.

In an embodiment, the magazine 1318 is capable of easily beingdisengaged from the tool 1300. This allows one or more cartridgescollected by the magazine to be unloaded from the tool 1300. In anembodiment, the detaching feature allows a magazine full of usedcartridges to be replaced with an empty removal magazine for continuinguse. In an embodiment, the removal magazine 1318 includes one or morewindows (not shown) to allow the user to view inside the magazine 1318and see the collected cartridges or an aperture for the ejection ofspent or used cartridges.

FIG. 23A illustrates a perspective view of a guidewire with integratedtension maintaining mechanism in accordance with an embodiment. As shownin FIG. 23A, the guidewire 1400 preferably includes a body 1406 having atension wire 1402 and a tension head 1404 coupled to a proximal end ofthe tension wire 1402.

The body 1406 has a diameter D, whereby the tension wire 1402 has adiameter d_(w), and the tension head 1404 has a width dimension w_(h).The diameter d_(w) of the tension wire 1402 is preferably smaller thanthe diameter D of the body 1406. Additionally, it is preferred that thewidth w_(h) of the tension head 1404 is greater than the diameter d_(w)of the tension wire 1402 but preferably smaller than the diameter D ofthe body 1406. The smaller width dimension w_(h) of the tension head1404 allows the user to load and unload other surgical tools via thehead 1404 and onto the coil body 1406 while simultaneously maintainingthe desired stiffness of the guidewire 1400.

The tension head 1404 has an integrated tension maintaining mechanism1410 in which the mechanism 1410 includes one or more channels which areconfigured to house tensioning legs, as shown in FIG. 23A. In theembodiment shown in FIG. 23A, the tension maintaining mechanism 1410includes channels 1412, 1414 and 1416, each preferably located near theangles of the triangular head 1404, although placement of the channelscan be anywhere on the head 1404. In an embodiment, the channels 1412,1414 and 1416 extend entirely through the tension head, whereby one ormore of the channels 1412, 1414 and 1416 have an aperture in surface1432 and opposing surface 1434. In an embodiment, the channels 1412,1414 and 1416 only extend out of surface 1434 of the tension head 1404.

The channels 1412, 1414 and 1416 preferably house respective tensionlegs 1418, 1420, 1422 which are slidably moveable in and out of thechannels in a linear direction. Each tension leg has a proximal endwhich preferably remains attached to the tension head 1404 and a distalend which comes in contact and abuts the collar 1408 of the guidewire1400. When in the retracted mode, as with legs 1420, 1422 in FIG. 23A,the legs 1420, 1422 remain within their respective channels 1420, 1422and preferably do not come into contact with the collar 1408. Incontrast, when the leg is in the extended mode, as with tension leg1418, the leg 1418 abuts the collar 1408 and forces the tension head1404 to remain positioned away from the collar 1408 to ensure that theguidewire maintains its desired stiffness. In an embodiment, it iscontemplated that the collar 1408 may include one or more detents 1430which are configured to receive the distal end of the respective tensionleg. The detents 1430 aid in stabilizing the tension leg in the extendedposition and prevent the tension leg from slipping off the surface ofthe collar 1408.

In an embodiment in which the mechanism 1410 utilizes more than onetension leg, it is preferred that the tension legs have different lengthdimensions, although this is optional. As shown in FIG. 23A, tension leg1420 has a greater length dimension compared to leg 1422, but a smallerlength dimension than leg 1418. Considering that the stiffness of theguidewire 1400 is directly proportional to the distance between thetension head 1404 and the collar 1408, the guidewire 1400 willexperience greater stiffness when tension leg 1418 is in the extendedposition than when tension leg 1420 is in the extended position. Incomparison, the guidewire 1400 will experience less stiffness whentension leg 1422 is in the extended position than when tension leg 1420is in the extended position. This allows the user to selectively choosewhich tension leg to utilize based on the desired stiffness of theguidewire 1400.

The tension legs 1418, 1420, 1422 are preferably attached to thechannels at their proximal ends to prevent the legs 1418, 1420, 1422from becoming disengaged from the tension head 1404. The mechanism 1410is configured to ensure that the extended tension leg is able towithstand the forces which urge the tension head 1404 to move toward thecollar 1408. In an embodiment, a spring (not shown) within the tensionhead 1404 urges the tension leg to the extended position, whereby thespring is rated with a constant k such that the spring force will behigher than any opposite force that urges head 1404 and collar 1408toward one another.

In an embodiment, FIG. 23B, an actuator 1424 which is attached to leg1418 protrudes out of an elongated aperture 1426 in the tension head1404, whereby the user can slidably move the actuator 1424 along anelongated aperture 1426 to slide the leg 1418 in or out of the head1404. As shown in FIG. 23B, the elongated aperture 1426 includes a stopdetent 1428 in which the actuator 1424 may be set to ensure that the leg1418 remains in the extended position to maintain the stiffness in theguidewire 1400. In the example shown in FIG. 23B, the stop detent 1428is positioned at the end of the window 1426 closest to the tension wire1402, although one or more intermediate stop detents may be configuredat desired locations along the elongated aperture 1426 to allow the userto achieve various intermediate lengths of the tension leg (andassociated stiffness from the guidewire) by locking the actuator 1424 inany of the desired intermediate detents.

In an embodiment, the tension head 1404 is configured to be rotatableabout an axis oriented along the length of the tension wire 1402. Thiswould allow the user to simply rotate the tension head 1404 to a desiredposition which may be less cumbersome for the user to extend or retracta tension leg based on the orientation of the guidewire 1400 during aprocedure. Alternatively, the tension head 1404 is not rotatable aboutthe tension wire 1402 and is fixedly coupled thereto.

In an embodiment, the integrated guidewire tension maintaining head maybe combined with a tool to actuate the tension legs. FIG. 24 illustratesa side view of the integrated guidewire tension maintaining head 1400with deployment tool 1500 in accordance with such an embodiment. Thedeployment tool 1500 preferably includes a handle member 1502, a triggermember 1504, an elongated tray 1508, a tension brace 1506, and a collarinterface 1510. Although the handle member 1502 is shown to have apistol grip and an elongated trigger member 1504, other appropriateshapes for the handle 1502 and/or trigger member 1504 are contemplated.

As shown in FIG. 24, the tension head 1404 is positioned within thedeployment tool 1500 between the handle 1502 and the tension brace 1506.The handle 1502 preferably includes an actuating pin 1512 positionedwithin a chamber 1514 therein, whereby the pin 1512 preferably extendsout of the handle 1502 when the trigger 1504 is depressed. The tool 1500preferably includes an aperture 1516 on the handle 1502 which is incommunication with the pin chamber 1514. In an embodiment, the aperture1516 is aligned with a receiving aperture 1436 of the tension head 1404such that the pin 1512, upon being actuated, extends out of the chamber1514 passes through aperture 1436 to press the tension leg 1418 out ofchannel 1412. As stated above, the tension leg 1418 extends out of head1404 to the extended position in which the leg 1418 abuts the collar1408.

In the embodiment in FIG. 24, the tension leg 1418 separates thedistance between the tension head 1404 and the collar 1408. It iscontemplated that the tension brace 1506 may aid in separating thetension head 1404 from the collar 1408 in that a combination of thetension brace 1506 and tension leg 1418 maintain stiffness of theguidewire. The tension brace 1506 preferably includes an aperture whichis aligned with the exit aperture 1438 of the tension head 1404 suchthat the tension leg 1418 passes through the tension brace 1506 andabuts the collar interface 1510.

As stated, the tension head 1404 is rigidly attached to the tension wire1402 and guidewire body 1406. In an embodiment, the tension head 1404 isrigidly attached to the deployment tool 1500. In an embodiment, thetension head 1404 is not rigidly attached to the deployment tool 1500,whereby the deployment tool 1500 may be used with different classes ofguidewires having differently dimensioned tension heads and/or tensionlegs.

It should be noted that the tension head 1404 is shown in FIGS. 23 and24 have a triangular shape. Although this is a preferred shape, thetension head 1404 may alternatively have any other shape including, butnot limited to, square, hexagonal, pentagonal, trapezoidal, spherical,circular, etc. It should be noted that the tension legs are shown in theFigures as bean-shaped, the tension legs may have any cross sectionalshape, such as square, circular, rectangular, etc. Although threechannels and tension legs are described above, it should be noted thatany number of channels and tension legs, such as one channel or leg, arecontemplated for a particular tension head.

While embodiments and applications have been shown and described, itwould be apparent to those skilled in the art having the benefit of thisdisclosure that many more modifications than mentioned above arepossible without departing from the inventive concepts disclosed herein.The invention, therefore, is not to be restricted except in the spiritof the appended claims.

1. A variable-stiffness guidewire system comprising: an elongatedflexible guidewire having a body and a guidewire head coupled to thebody, the guidewire including a guidewire collar proximal to theguidewire head, the guidewire head slidably moveable with respect to theguidewire collar of the body via a tensioning wire to adjust a stiffnessof at least a portion of the guidewire; and an insert coupled to theguidewire and positioned between the guidewire head and the guidewirecollar, the insert having a cross-sectional dimension no larger than adiameter of the body, the insert configured to maintain a distance ofthe guidewire head from the guidewire collar to maintain a desiredstiffness in the at least a portion of the guidewire.
 2. The system ofclaim 1, wherein the insert further comprises a cylindrical body havinga first end and a second end opposite from the first end, wherein thefirst end abuts the guidewire head and the second end abuts theguidewire collar.
 3. The system of claim 2, wherein the cylindrical bodyfurther comprises an aperture running through the body between the firstand second ends, wherein at least a portion of the aperture isconfigured to receive a tensioning wire of the guidewire therein.
 4. Thesystem of claim 3, wherein the cylindrical body further comprises aplurality of opposing faces adjacent to the aperture, each faceextending between the first and second ends of the body, wherein a forceapplied on to either or both of the opposing faces increases a diameterof the aperture.
 5. The system of claim 2, wherein the cylindrical bodyis circular in cross-section.
 6. The system of claim 3, wherein thecylindrical body further comprises a first portion and a second portionhingedly coupled to one another and pivotably moveable with respect toone another between an open position and a closed position.
 7. Thesystem of claim 2, wherein the cylindrical body further comprises aridge feature extending from an end of the cylindrical body.
 8. Thesystem of claim 2, wherein the cylindrical body further comprises agroove feature in an end of the cylindrical body.
 9. Avariable-stiffness guidewire system to be used with an external medicaldevice, the system comprising: an elongated flexible guidewire having abody and a guidewire head coupled to the body, the guidewire having aguidewire collar proximal to the guidewire head, the guidewire headslidably moveable with respect to the guidewire collar via a tensioningwire to adjust a stiffness of at least a portion of the guidewire, thebody configured to move through a lumen of an external medical device;and an insert coupled to the guidewire and positioned between theguidewire head and the guidewire collar to maintain a desired stiffnessin the at least a portion of the guidewire, the insert having across-sectional dimension such that a lumen of an external medicaldevice may be passed over the guidewire while the insert is coupledtherewith.
 10. The system of claim 9, wherein the insert furthercomprises a cylindrical body having a first end and a second endopposite from the first end, wherein the first end abuts the guidewirehead and the second end abuts the guidewire collar.
 11. The system ofclaim 10, wherein the cylindrical body further comprises an aperturerunning through the body between the first and second ends, wherein atleast a portion of the aperture is configured to receive a tensioningwire of the guidewire therein.
 12. The system of claim 10, wherein thecylindrical body further comprises a plurality of opposing facesadjacent to the aperture, each face extending between the first andsecond ends of the body, wherein a force applied on to either or both ofthe opposing faces increases a diameter of the aperture.
 13. The systemof claim 11, wherein the cylindrical body is circular in cross-section.14. The system of claim 13, wherein the cylindrical body furthercomprises a first portion and a second portion hingedly coupled to oneanother and pivotably moveable with respect to one another between anopen position and a closed position.
 15. The system of claim 10, whereinthe cylindrical body further comprises a ridge feature extending from anend of the cylindrical body.
 16. The system of claim 11, wherein thecylindrical body further comprises a groove feature in an end of thecylindrical body.
 17. A tension maintaining insert for use with avariable-stiffness guidewire having a guidewire head moveable withrespect to a guidewire collar of a guidewire body to control a stiffnessof the guidewire, the insert comprising: a cylindrical body having across-sectional dimension no larger than a diameter of a body of aguidewire, the cylindrical body configured to be positioned between theguidewire head and the guidewire collar to maintain a stiffness of theguidewire.
 18. The insert of claim 17, wherein the cylindrical bodyfurther comprises a first end and a second end opposite from the firstend, wherein the first end abuts the guidewire head and the second endabuts the guidewire collar.
 19. The insert of claim 18, wherein thecylindrical body further comprises an aperture running through the bodybetween the first and second ends, wherein at least a portion of theaperture is configured to receive a tensioning wire of the guidewiretherein.
 20. The insert of claim 19, wherein the cylindrical bodyfurther comprises a plurality of opposing faces adjacent to theaperture, each face extending between the first and second ends of thebody, wherein a force applied on to either or both of the opposing facesincreases a diameter of the aperture.